BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE & I-STAT G3+ CARTRIDGE

    MDR report key: 1770247 · Received July 20, 2010

    Report

    Report Number
    2245578-2010-00040
    Event Type
    Malfunction
    Date Received
    July 20, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG # 06F03-01; LOT # P10033. DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. (B) (4).

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO NOTIFY THE CUSTOMER AND REMOVE AFFECTED PRODUCT FROM THE FIELD. ABBOTT POINT OF CARE HAS DETERMINED SPECIFIC BOXES OF CG8+ LOT T10036A AND G3+ P10033 MAY GENERATE FALSELY ELEVATED PCO2 RESULTS. ABBOTT POINT OF CARE HAS MADE THE DECISION TO NOTIFY CUSTOMERS OF THE ISSUE AND REMOVE THE SPECIFIC BOXES OF THE CARTRIDGE LOTS FROM THE MARKETPLACE TO ENSURE THE PERFORMANCE OF OUR PRODUCT. THIS ACTION WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CG8+ CARTRIDGE & I-STAT G3+ CARTRIDGE CG8+ CARTRIDGE & G3 CARTRIDGE CHL ABBOTT POINT OF CARE T10036A

    Patients

    Seq Age Sex Outcome Treatment
    1